Overview:
TekWissen Group is a workforce managementprovider throughout the USA and many other countries in the world.This client is a German multinational Pharmaceutical andbiotechnology company and one of the largest pharmaceuticalcompanies in the world headquartered in Leverkusen and areas ofbusiness include pharmaceuticals; consumer healthcare productsagricultural chemicals seeds and biotechnology products.
Job Title: Manufacturing Technician(Expert)Production InfrastructPRODCS
Location: Berkeley CA94710
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Description:
* Responsible for clinical manufacturing of cell therapyDS/DP within the Cell Culture Technology Center (CCTC).
* Collaborates closelywith biological development (BD) and Manufacturing Science andTechnology (MSAT) for new product introductions and ensure platformalignment.
POSITION DUTIES &RESPONSIBILITIES
* Responsible for all aspects ofclinical manufacturing in the following areas: Cell Expansion CellCulture Differentiation Filling Visual Inspection SolutionPreparation and Weigh/Dispense.
* Employee will move with the process and work seamlesslyacross all areas.
* Ensures all activities are performed to schedule.
* Manufacturesproducts in various phases of product life cycles from clinicalthru launch. Clearly understands communicates and managesdifferences in terms of documentation sample handling automationand cGMPs etc. for different phases of product life cycle.
* Provide feedbacks tohandles and troubleshoots single use technology (SUT) from end toend in manufacturing process.
* Works cross functionally to ensure process is controlledand issues are escalated and investigated.
* Redlines and reviews controlled documents forvarious equipment/processes.
* Effectively employs all methods of communication (oralwritten presentation) to ensure knowledge and information transferacross shifts to management and cross functionally.
* Raises and supports investigationof deviations.
* Participates in safety investigations for CCTC andpromotes safe behaviors at all times.
* Must be able to change shift schedule basedon business and process needs.
* Must provide offhour (night and weekend includingholiday) coverage to meet business requirements on short notice.
* Ability to lift 45lb.
REQUIREMENTS/PREFERENCES
Education Requirement(s):
* Minimum of BS in science related field ispreferred
* Must havea minimum of 2 years experience.
* Transferable skills will be considered. or anequivalent combination of education and experience.
Skill & Competency Requirements:
* Demonstrates strong tendency towardsindependent thinking and decision making.
* Able to make logical decisions independentlyfor multiple process work streams with limited information orsupervision available.
* Works with highest level of flexibility.
* Responds easily to last minutechanges to production schedule.
* Must be Experienced in cGMP and GDP requirements forpharmaceutical manufacturing.
Preferences:
* Experienced with data integrity regulatoryrequirements for pharmaceutical manufacturing.
* Experienced in operation of bagfiller pumps BSCs welders/sealers environmental monitoringequipment.
* Experienced with business IT systems (Delta V SAP etc )
* Experienced withMicrosoft Office. Excellent computer skills.
TekWissen Group is an equal opportunityemployer supporting workforce diversity.